[Federal Register Volume 60, Number 237 (Monday, December 11, 1995)]
[Notices]
[Page 63538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30003]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: Antibacterial Therapy 
With Bacteriophage Genotypically Modified to Delay Inactivation by the 
Host Defense System

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice in accordance with 15 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i) that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive world-wide license to practice the inventions embodied in 
U.S. Patent Application 08/222,956 and corresponding foreign patent 
applications entitled, ``Antibacterial Therapy with Bacteriophage 
Genotypically Modified to Delay Inactivation by the Host Defense 
System'' to Exponential Therapies, Inc., New York, New York 10001. The 
patent rights in these inventions have been assigned to the United 
States of America.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless within sixty 
(60) days from the date of this published notice, NIH receives written 
evidence and argument that the grant of the license would not be 
consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. 
Alternatively, the subject technology may be licensed as a CRADA 
invention under 15 U.S.C. 3701 et seq. if it is determined to have been 
made in whole or in part under CRADA 94/0023.
    The patent application concerns bacteriophage therapy and discloses 
methods that enable bacteriophage to delay inactivation by any and all 
parts of the host defense system (HDS) against foreign objects that 
would tend to reduce the numbers of bacteriophage and/or the efficiency 
of those phage at killing the host bacteria present during an 
infection. The application discloses two method for producing 
genotypically modified bacteriophage: (1) Selection by serial passaging 
and (2) genetic engineering. The foregoing methods can be used to 
manufacture a variety of distinct therapeutics for antibiotic-resistant 
bacterial diseases.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Girish C. Barua, Ph.D., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7735 ext. 
263; facsimile: 301/402-0220. A signed Confidentiality Agreement will 
be required to receive copies of the patent applications. Applications 
for a license in the indicated exclusive field(s) of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated license. Only written comments and/or applications for 
a license which are received by NIH on or before February 9, 1996 will 
be considered. Comments and objections submitted in response to this 
notice will not be made available for public inspection and, to the 
extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: December 1, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-30003 Filed 12-8-95; 8:45 am]
BILLING CODE 4140-01-M@